The skin is the largest organ of the human body, and its numerous diseases manifest themselves as anomalous formations, featuring a wide range of sizes, shapes and colors. Such anomalous formations are often cosmetically unappealing, but only in seldom cases represent a danger to life.
The standard therapy used for skin tumor treatment is determined by many factors, including the exact histologic subtype, the tumor size, the growth characteristics and the anatomic location. Treatment is also determined by the previous treatment received, current medical problems and the patient's expectations.
Treatment options may be categorized as surgical and non-surgical. Surgical treatments include laser or electrodessication and curettage, simple or wide local excision of the lesion or Mohs micrographic surgery. Non-surgical treatments include radiation therapy, photodynamic therapy, cryotherapy and topical drug therapy.
One of the prevailing methods of tumor skin lesions treatment with a topical application involves the use of a drug with sufficient corrosive activity consisting of mineral and organic acids. Practically almost all aggressive chemicals can show necrotizing action on a skin depending on the concentration and quantity of chemicals, the mechanism of their influence, degree of penetration and duration of exposure.
Topical applications are oftentimes preferred over laser therapy or cryotherapy because they can minimize any potential systemic adverse effects of drug, are easier to conduct and less expensive.
U.S. Pat. Nos. 4,595,591 and 5,573,786 describe compositions consisting of nitric acid and nitrous acid or metal nitrite. However, adequate results using SOLCODERM™ (a medication manufactured and distributed by Solco Basel AG (Switzerland)) are achieved only if the recommended storage temperature and the use-by dates indicated are observed as accurately as possible, since fluctuations in the nitrite concentration during a long-time storage may severely decrease the effectiveness of medication. In addition, it has been observed that medication such as SOLCODERM™, when inactive, present an increased danger of side effects.
U.S. Pat. No. 7,128,903 suggests a preparation, consisting of trichloracetic, hydrochloric and formic acids.
U.S. Pat. Nos. 4,380,549, 5,091,171 and 5,407,958 suggest preparations based on alpha-hydroxycarboxylic acid including salicylic acid.
In prior EP No. 1 293 498 entitled “Selenium complex with haloethanoic acid or its anhydride, and use thereof in the topical treatment of neoplasms,” Mardi et. al. described and claimed the compounds which can have the therapeutic efficacy in topical treatment of inflammatory skin conditions.
The closest analogue of the present disclosure in terms of the technical characteristics is our most recent RU 2366648 entitled “The product of interaction between selenious dioxide and aliphatic haloid carboxylic acids, the method of production preparation and the method of treatment of benign, viral, premalignant, and malignant non-metastasizing skin lesions, of dysplastic lesions of visible mucous coats, fungous and other skin diseases.” It was described here that aliphatic alpha-haloidcarboxylic acids and related compounds are therapeutically effective for topical treatment of various cosmetic conditions and dermatologic disorders including more than 70 nosologies of skin lesions in humans. According to this patent, the preparation of complex compounds of general formula H2SeO3xRCXY(CH2)mCOOH is achieved by heating selenious dioxide with aliphatic haloid carboxylic acids, followed by filtering.
The disadvantages of this method are the instability of solutions of the semi-finished product (substance) and the dosage band, low and uncontrollable concentration of selenium and the impossibility of its regulation. The compositions recommended for the practical application, were resolving while in storage, and the process was accompanied by the selenium precipitation, which is unacceptable.
Some of the disadvantages of the pharmaceutical composition under prior art usually were opened only after long-term tests and in practical applications
Drugs are products whose quality the consumer can not appreciate at its true value. Therefore, a guarantee of quality, safety and efficacy of drugs is the responsibility of the manufacturer and is provided by checking these indicators through at all stages of the drug life cycle.
Precipitation when storing pharmaceutical substances is a typical example of chemical incompatibility. The products of such reactions lose most of their therapeutic effects probably because the penetration in skin and distribution of the active ingredients to the target site are generally diminished.
Incompatibility ingredients of drugs are often successfully addressed using adjuvants or special kinds of packing.
The above brief review clearly indicates that there is an urgent need to develop a new, simple, rapid, highly safe, highly effective method of production of the pharmaceutical compositions for topical treatment of skin diseases.
The present disclosure aimed to achieve the above objectives will now be described in more detail with reference to following examples that are merely illustrative of the compositions and methods of the present invention and are not intended to be limiting.